Primary Care Medicine, including Family Practice and Pediatrics, has traditionally relied on physical exam skills and simplistic instruments for critical diagnostic decision making, monitoring, and referral to medical specialists. The otoscope and ophthalmoscope are two historical and ubiquitous instruments that largely only illuminate and magnify tissue surfaces in the ear and eye, respectively. This Partnership will develop a new Primary Care Imaging system integrating optical coherence tomography (OCT) imaging with these instruments in a handheld scanner and portable system to advance the technological diagnostic and monitoring capabilities in primary care, and more effectively manage and refer patients based on quantitative data. A partnership composed of collaborating academic, clinical, and industrial institutions and investigators will develop and clinically evaluate this new point-of-care diagnostic technology. OCT is the optical analogue to ultrasound imaging, but generates 3-D images based on the backscatter of near-infrared light rather than sound. This Primary Care Imaging system with a MEMS-based handheld scanner and interchangeable tips enables high-resolution real-time 3-D imaging of the multiple tissue sites commonly examined during primary care outpatient exams including the eyes, ears, oral and nasal mucosa, skin, and cervix. For this project, system demonstration will focus on two increasingly prevalent diseases encountered in the primary care office, namely otitis media (middle ear infections) and diabetic retinopathy. Recent evidence has strongly associated chronic, recurrent episodes of otitis media with the presence of middle ear bacterial biofilms, and currently no non-invasive means exists to detect and quantify, let alone longitudinally monitor, these structures, which act as reservoirs to antibiotic-resistant bacterial for seeding recurrent infections. OCT enables quantitative assessment of middle ear biofilms and effusions, with the potential to significantly improve the antibiotic regimens and clinical management of this common disease. The rapidly rising prevalence of obesity has already been followed by increases in diabetes among increasingly younger patients, along with the associated complications of this disease, such as diabetic retinopathy. The successful use of OCT in ophthalmology can subsequently be advanced to the front-line of primary care to monitor patients for early evidence of diabetic retinopathy, and to quantify longitudinal changes during treatment. With an increasing reliance on effective primary care patient management for the expected increase in numbers of patients, new advanced diagnostic and quantitative technologies and instruments are needed in the outpatient primary care clinic for the early detection of disease, for quantitative monitoring of disease progression or regression, and for more efficient and evidence-based referrals to medical specialists. This Primary Care Imaging system addresses this critical need, and for the first time, brings advanced diagnostic imaging technology to the primary care office. PUBLIC HEALTH RELEVANCE: Primary Care Medicine has traditionally relied on physical exam skills and simplistic instruments for critical diagnostic decision making, monitoring, and referral to medical specialists. The otoscope and ophthalmoscope are two ubiquitous instruments that largely only illuminate and magnify tissue surfaces in the ear and eye, respectively. This Partnership will develop a new Primary Care Imaging system integrating optical coherence tomography imaging with these instruments in a handheld scanner and portable system to advance the technological diagnostic and monitoring capabilities in Primary Care, and more effectively manage and refer patients based on quantitative data.